Surgical probe for supporting inflatable therapeutic devices in contact with tissue in or around body orifice and within tumors

ABSTRACT

A probe that facilitates the creation of lesions in bodily tissue. The probe includes a relatively short shaft and an inflatable therapeutic element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/027,622, filed Dec. 30, 2004, which is a continuation of U.S.application Ser. No. 09/737,176, filed Dec. 13, 2000, now U.S. Pat. No.6,837,885, which is a continuation-in-part of U.S. application Ser. No.09/083,874, filed May 22, 1998, now U.S. Pat. No. 6,428,537, which isincorporated herein in its entirety.

BACKGROUND OF THE INVENTIONS

1. Field of Inventions

The present inventions relate generally to surgical probes that supporttherapeutic devices in contact with body tissue.

2. Description of the Related Art

There are many instances where diagnostic and therapeutic elements mustbe inserted into the body. One instance involves the treatment ofcardiac conditions such as atrial fibrillation and atrial flutter whichlead to an unpleasant, irregular heart beat, called arrhythmia.

Normal sinus rhythm of the heart begins with the sinoatrial node (or “SAnode”) generating an electrical impulse. The impulse usually propagatesuniformly across the right and left atria and the atrial septum to theatrioventricular node (or “AV node”). This propagation causes the atriato contract in an organized way to transport blood from the atria to theventricles, and to provide timed stimulation of the ventricles. The AVnode regulates the propagation delay to the atrioventricular bundle (or“HIS” bundle). This coordination of the electrical activity of the heartcauses atrial systole during ventricular diastole. This, in turn,improves the mechanical function of the heart. Atrial fibrillationoccurs when anatomical obstacles in the heart disrupt the normallyuniform propagation of electrical impulses in the atria. Theseanatomical obstacles (called “conduction blocks”) can cause theelectrical impulse to degenerate into several circular wavelets thatcirculate about the obstacles. These wavelets, called “reentrycircuits,” disrupt the normally uniform activation of the left and rightatria.

Because of a loss of atrioventricular synchrony, the people who sufferfrom atrial fibrillation and flutter also suffer the consequences ofimpaired hemodynamics and loss of cardiac efficiency. They are also atgreater risk of stroke and other thromboembolic complications because ofloss of effective contraction and atrial stasis.

One surgical method of treating atrial fibrillation by interruptingpathways for reentry circuits is the so-called “maze procedure” whichrelies on a prescribed pattern of incisions to anatomically create aconvoluted path, or maze, for electrical propagation within the left andright atria. The incisions direct the electrical impulse from the SAnode along a specified route through all regions of both atria, causinguniform contraction required for normal atrial transport function. Theincisions finally direct the impulse to the AV node to activate theventricles, restoring normal atrioventricular synchrony. The incisionsare also carefully placed to interrupt the conduction routes of the mostcommon reentry circuits. The maze procedure has been found veryeffective in curing atrial fibrillation. However, the maze procedure istechnically difficult to do.

Maze-like procedures have also been developed utilizing catheters whichcan form lesions on the endocardium (the lesions being 1 to 15 cm inlength and of varying shape) to effectively create a maze for electricalconduction in a predetermined path. The formation of these lesions bysoft tissue coagulation (also referred to as “ablation”) can provide thesame therapeutic benefits that the complex incision patterns that thesurgical maze procedure presently provides.

Catheters used to create lesions typically include a relatively long andrelatively flexible body portion that has a soft tissue coagulationelectrode on its distal end and/or a series of spaced tissue coagulationelectrodes near the distal end. The proximal end of the flexible body istypically connected to a handle which includes steering controls. Theportion of the catheter body portion that is inserted into the patientis typically from 58.4 cm to 139.7 cm in length and there may be another20.3 cm to 38.1 cm, including a handle, outside the patient. The lengthand flexibility of the catheter body allow the catheter to be insertedinto a main vein or artery (typically the femoral artery), directed intothe interior of the heart, and then manipulated such that thecoagulation electrode contacts the tissue that is to be ablated. Linearand curvilinear lesions can then be created by dragging a singleelectrode or by applying power (preferably simultaneously) to the seriesof spaced electrodes.

Catheter-based soft tissue coagulation has proven to be a significantadvance in the medical arts generally and in the treatment of cardiacconditions in particular. Nevertheless, the inventors herein havedetermined that catheter-based procedures are not appropriate in everysituation and that conventional catheters are not capable of reliablyforming all types of lesions. For example, one lesion that has proven tobe difficult to form with conventional catheter devices is thecircumferential lesion that is used to isolate the pulmonary vein andcure ectopic atrial fibrillation. Lesions that isolate the pulmonaryvein may be formed within the pulmonary vein itself or in the tissuesurrounding the pulmonary vein. These circumferential lesions are formedby dragging a tip electrode around the pulmonary vein or by creating agroup of interconnected curvilinear lesions one-by-one around thepulmonary vein. Such techniques have proven to be less than effectivebecause they are slow and gaps of conductive tissue can remain after theprocedure. It can also be difficult to achieve the adequate tissuecontact with conventional catheters.

Accordingly, the inventors herein have determined that a need exists forstructures that can be used to create circumferential lesions within oraround bodily orifices and, in the context of the treatment of atrialfibrillation, within or around the pulmonary vein.

Another instance where therapeutic elements are inserted into the bodyis the treatment of tumors, such as the cancerous tumors associated withbreast cancer and liver cancer. Heretofore, tumors have been treatedwith highly toxic drugs that have proven to have severe side effects.More recently, devices including a plurality of needle-like electrodeshave been introduced. The needle-like electrodes may be directed intothe tumor tissue and used to deliver RF energy. The associated currentflow heats the tissue and causes it to coagulate.

The inventors herein have determined that there are a number ofshortcomings associated with the use of needle-like electrodes tocoagulate tissue. Most notably, the needle-like electrodes producenon-uniform, shallow lesions and/or spot lesions and also fail tocoagulate the entire volume of tumor tissue. This failure can ultimatelyresult in the tumor growing to be even larger than its original size.The needle-like electrodes can also cause tissue charring. Moreover,tissue tends to shrink around the needle-like electrodes during thecoagulation process. This makes it very difficult to withdraw theelectrodes from the patient and often results in tissue trauma.

Accordingly, the inventors herein have determined that a need exists fora device that can completely and uniformly coagulate large volumes oftissue without charring and can also be removed from the patient withoutthe difficulty associated with needle-like electrodes.

SUMMARY OF THE INVENTION

Accordingly, the general object of the present inventions is to providea device that avoids, for practical purposes, the aforementionedproblems. In particular, one object of the present inventions is toprovide a device that can be used to create circumferential lesions inor around the pulmonary vein and other bodily orifices in a moreefficient manner than conventional apparatus.

In order to accomplish some of these and other objectives, a surgicalprobe in accordance with one embodiment of a present invention includesa relatively short shaft and an inflatable therapeutic elementassociated with the distal portion of the shaft. In a preferredembodiment, the therapeutic element will be configured so that it canform a continuous lesion around a pulmonary vein.

Such a probe provides a number of advantages over conventionalapparatus. For example, the present surgical probe may be used duringopen heart surgery or in less invasive procedures where access to theheart is obtained via a thoracostomy, thoracotomy or median sternotomy.The relatively short shaft and manner in which access is obtained allowsthe therapeutic element to be easily inserted into the heart and placedagainst the target tissue with the desired level of contact, therebyeliminating many of the problems associated with catheter-basedprocedures. Moreover, the present therapeutic element may be used toform lesions in an annular region of tissue within or around thepulmonary vein (or other orifice in other procedures) in one step,thereby eliminating the need to either drag a tip electrode around anannular region or form a number of interconnected curvilinear lesionsthat is associated with catheter-based procedures.

Additionally, in accordance with a preferred embodiment, the flexibilityof the inflatable therapeutic element may be varied as appropriate. Thisallows the physician to achieve the appropriate level of tissue contact,even when the shaft is not perfectly perpendicular to the target tissuearea, the target tissue area is somewhat uneven, or the target tissuehas become rigid due to calcification.

In accordance with another preferred embodiment, the inflatabletherapeutic element will be configured such that it can be inserted intoa tumor (or other target location), inflated and then used to uniformlycoagulate the entire tumor (or a large volume of tissue associate withthe other location) without charring. Once the coagulation procedure iscomplete, the inflatable therapeutic element can be deflated and removedfrom patient without the difficulty and trauma associated withneedle-like electrodes.

In order to accomplish some of these and other objectives, a surgicalprobe in accordance with one embodiment of a present invention includeshollow needle and a therapeutic assembly, located within the hollowneedle and movable relative thereto, having a relatively short shaft andan inflatable therapeutic element associated with the distal portion ofthe shaft. The hollow needle may be used to pierce through tissue toenter a target location such as a tumor. Prior to coagulation, thehollow needle may be withdrawn and the inflatable therapeutic elementheld in place within the tumor. The therapeutic element may then beinflated and the tissue coagulated. When the coagulation procedure iscomplete, the therapeutic element may be deflated and withdrawn backinto the hollow needle.

In order to accomplish some of these and other objectives, a surgicalprobe in accordance with one embodiment of a present invention includesone or more needles having inflatable porous therapeutic elementsmounted thereon. The needles may be directed into tissue, such as tumortissue for example, in a manner similar to conventional needleelectrodes. Here, however, conductive fluid within the inflatable poroustherapeutic elements will draw heat away from the therapeutic elementand the adjacent tissue. Such heat transfer results in the formation ofrelatively deep, large volume lesions without the charring andcoagulation associated with conventional needle electrodes.

The above described and many other features and attendant advantages ofthe present inventions will become apparent as the inventions becomebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of preferred embodiments of the inventions will bemade with reference to the accompanying drawings.

FIG. 1 is a side view of a surgical probe in accordance with a preferredembodiment of a present invention.

FIG. 2 is a section view taken along line 2-2 in FIG. 1.

FIG. 3 is a cutaway view of the distal portion of the exemplary surgicalprobe illustrated in FIG. 1.

FIG. 4 is a front view of the exemplary surgical probe illustrated inFIG. 1.

FIG. 5 is a section view taken along line 5-5 in FIG. 3.

FIG. 6 is rear view of the exemplary surgical probe illustrated in FIG.1 with the fluid lumens removed.

FIG. 7 is a side view showing the exemplary surgical probe illustratedin FIG. 1 connected to a fluid supply and a power supply.

FIG. 8 is a side view of a surgical probe in accordance with a preferredembodiment of a present invention.

FIG. 9 is a side view of a surgical probe in accordance with a preferredembodiment of a present invention.

FIG. 10 is a partial section view of the distal portion of the surgicalprobe illustrated in FIG. 9.

FIG. 11 is a side view of the distal portion of a surgical probe inaccordance with a preferred embodiment of a present invention.

FIG. 12 is a side view of a surgical probe in accordance with apreferred embodiment of a present invention.

FIG. 13 is an enlarged view of one of the needles in the surgical probeillustrated in FIG. 12.

FIG. 14 is a partial section view of a portion of one of the needles inthe surgical probe illustrated in FIG. 12.

FIG. 15 is a section view taken along line 15-15 in FIG. 13.

FIG. 16 is a section view taken along line 16-16 in FIG. 13.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

This specification discloses a number of probe structures, mainly in thecontext of cardiac ablation, because the structures are well suited foruse with myocardial tissue. For example, the present inventions aredesigned to produce intimate tissue contact with target substratesassociated with arrhythmias such as atrial fibrillation. One applicationis the creation of lesions within or around the pulmonary vein to treatectopic atrial fibrillation. Nevertheless, it should be appreciated thatthe structures are applicable for use in therapies involving other typesof soft tissue. For example, various aspects of the present inventionshave applications in procedures concerning other regions of the bodysuch as the prostate, liver, brain, gall bladder, uterus and other solidorgans.

As illustrated for example in FIGS. 1-7, a surgical probe 10 inaccordance with a preferred embodiment of a present invention includes arelatively short shaft 12, an inflatable therapeutic element 14 and ahandle 16. The relatively short shaft 12 will typically be between 10.1cm and 45.7 cm in length, and is preferably about 17.8 cm in length,while the outer diameter of the shaft is preferably between about 6 and24 French.

Force is applied through the shaft 12 in order to achieve theappropriate level of tissue contact. Thus, the shaft 12 should besufficiently strong to prevent collapse when the force is applied and ispreferably relatively stiff. As used herein the phrase “relativelystiff” means that the shaft 12 (or other structural element) is eitherrigid, malleable, or somewhat flexible. A rigid shaft cannot be bent. Amalleable shaft is a shaft that can be readily bent by the physician toa desired shape, without springing back when released, so that it willremain in that shape during the surgical procedure. Thus, the stiffnessof a malleable shaft must be low enough to allow the shaft to be bent,but high enough to resist bending when the forces associated with asurgical procedure are applied to the shaft. A somewhat flexible shaftwill bend and spring back when released. However, the force required tobend the shaft must be substantial. Rigid and somewhat flexible shaftsare preferably formed from stainless steel, while malleable shafts areformed from fully annealed stainless steel.

In the illustrated embodiment, the shaft 12 consists of a hypotube 18with an outer polymer jacket 20 and includes a proximal portion 22 and adistal portion 24, both of which are malleable. The proximal portion 22is, however, stiffer than the distal portion 24. The proximal portion 22is also longer (about 11.5 cm) than the distal portion 24 (about 6.4cm).

One method of quantifying the flexibility of a shaft, be it shafts inaccordance with the present inventions or the shafts of conventionalcatheters, is to look at the deflection of the shaft when one end isfixed in cantilever fashion and a force normal to the longitudinal axisof the shaft is applied somewhere between the ends. Such deflection (σ)is expressed as follows:σ=WX ²(3L−X)/6EI

where:

W is the force applied normal to the longitudinal axis of the shaft,

L is the length of the shaft,

X is the distance between the fixed end of the shaft and the appliedforce,

E is the modulous of elasticity, and

I is the moment of inertia of the shaft.

When the force is applied to the free end of the shaft, deflection canbe expressed as follows:σ=WL ³/3EIAssuming that W and L are equal when comparing different shafts, therespective E and I values will determine how much the shafts will bend.In other words, the stiffness of a shaft is a function of the product ofE and I. This product is referred to herein as the “bending modulus.” Eis a property of the material that forms the shaft, while I is afunction of shaft geometry, wall thickness, etc. Therefore, a shaftformed from relatively soft material can have the same bending modulusas a shaft formed from relatively hard material, if the moment ofinertia of the softer shaft is sufficiently greater than that of theharder shaft.

For example, a relatively stiff 5.1 cm shaft (either malleable orsomewhat flexible) would have a bending modulus of at leastapproximately 28 N-cm² (1 lb.-in.²). Preferably, a relatively stiff 5.1cm shaft will have a bending modulus of between approximately 86 N-cm²(3 lb.-in.²) and approximately 1435 N-cm² (50 lb.-in.²). By comparison,5.1 cm piece of a conventional catheter shaft, which must be flexibleenough to travel through veins, typically has bending modulus betweenapproximately 2.8 N-cm² (0.11b.-in.²) and approximately 8.6 N-cm² (0.3lb.-in.²). It should be noted that the bending modulus ranges discussedhere are primarily associated with initial deflection. In other words,the bending modulus ranges are based on the amount of force, applied atand normal to the free end of the longitudinal axis of the cantileveredshaft, that is needed to produce 2.5 cm of deflection from an at rest(or no deflection) position.

As noted above, the deflection of a shaft depends on the composition ofthe shaft as well as its moment of inertia. The shaft could be made ofpolymeric material, metallic material or a combination thereof. Bydesigning the shaft 12 to be relatively stiff (and preferablymalleable), the present surgical probe is better adapted to theconstraints encountered during the surgical procedure. The forcerequired to bend a relatively stiff 5.1 cm long shaft should be in therange of approximately 6.7 N (1.5 lbs.) to approximately 53.4 N (12lbs.). By comparison, the force required to bend a 5.1 cm piece ofconventional catheter shaft should be between approximately 0.9 N (0.2lb.) to 1.1 N (0.25 lb.). Again, such force values concern the amount offorce, applied at and normal to the free end of the longitudinal axis ofthe cantilevered shaft, that is needed to produce 2.5 cm of deflectionfrom an at rest (or no deflection) position.

Ductile materials are preferable in many applications because suchmaterials can deform plastically before failure. Materials areclassified as either ductile or brittle, based upon the percentage ofelongation before failure. A material with more than 5 percentelongation prior to fracture is generally considered ductile, while amaterial with less than 5 percent elongation prior to fracture isgenerally considered brittle.

Alternatively, the shaft 12 could be a mechanical component similar toshielded (metal spiral wind jacket) conduit or flexible Loc-Line®, whichis a linear set of interlocking ball and socket linkages that can have acenter lumen. These would be hinge-like segmented sections linearlyassembled to make the shaft.

Turning to FIGS. 3 and 4, the exemplary inflatable therapeutic element14 is formed from an electrically non-conductive or semi-conductivethermoplastic or thermosetting plastic material and includes a forwardfacing porous region 26 having micropores 28 and non-porous regions 30.Fluid pressure is used to inflate the therapeutic element 14 andmaintain it in its expanded state in the manner described below. Thefluid used to fill the therapeutic element 14 is an electricallyconductive fluid that establishes an electrically conductive path toconvey RF energy from the porous region 26 to tissue.

Although other shapes (such as oval, triangular and rectangular) andsizes may be employed, the exemplary inflatable therapeutic element 14is substantially circular in cross section has a diameter between about1.0 cm to about 3.0 cm at its widest point when inflated. A preferredinflated diameter is about 1.5 cm. The forward facing porous region 26,which will have a width of about 1 mm to about 6 mm, is perpendicular tothe longitudinal axis of the shaft 12. Such shapes and sizes are wellsuited for use with pulmonary veins because they allow the porous region26 to be placed directly in contact with the targeted tissue area by aphysician during open heart surgery. Nevertheless, other inflatabletherapeutic element configurations, such as those where the entireforward facing half is porous, a solid circular portion of the forwardfacing half is porous, or the entire element is porous, may be employedas applications dictate.

Referring more specifically to FIG. 3, an electrode 32 is carried withinthe exemplary inflatable therapeutic element 14. The electrode 32 shouldbe formed from material with both relatively high electricalconductivity and relatively high thermal conductivity. Suitablematerials for the electrode 32, the length of which preferably rangesfrom about 1 mm to 6 mm, include gold, platinum, and platinum/iridium.Noble metals are preferred. The micropores 28 establish ionic transportof the tissue coagulating energy from the electrode 32 through theelectrically conductive fluid to tissue outside the therapeutic element14.

The electrically conductive fluid preferably possesses a low resistivityto decrease ohmic loses and thus ohmic heating effects within thetherapeutic element 14. The composition of the electrically conductivefluid can vary. A hypertonic saline solution, having a sodium chlorideconcentration at or near saturation, which is about 20% weight by volumeis preferred. Hypertonic saline solution has a low resistivity of onlyabout 5 ohm-cm, compared to blood resistivity of about 150 ohm-cm andmyocardial tissue resistivity of about 500 ohm-cm. Alternatively, thefluid can be a hypertonic potassium chloride solution. This medium,while promoting the desired ionic transfer, requires closer monitoringof the rate at which ionic transport occurs through the micropores 28,to prevent potassium overload. When hypertonic potassium chloridesolution is used, it is preferred to keep the ionic transport rate belowabout 1 mEq/min.

Due largely to mass concentration differentials across the micropores28, ions in the conductive fluid will pass into the pores because ofconcentration differential-driven diffusion. Ion diffusion through themicropores 28 will continue as long as a concentration gradient ismaintained across the therapeutic element 14. The ions contained in themicropores 28 provide the means to conduct current across thetherapeutic element 14. When RF energy is conveyed from a RF powersupply and control apparatus to the electrode 32, electric current iscarried by the ions within the micropores 28. The RF currents providedby the ions result in no net diffusion of ions, as would occur if a DCvoltage were applied, although the ions do move slightly back and forthduring the RF frequency application. This ionic movement (and currentflow) in response to the applied RF field does not require perfusion offluid through the micropores 28. The ions convey RF energy through themicropores 28 into tissue to a return electrode, which is typically anexternal patch electrode (forming a unipolar arrangement).Alternatively, the transmitted energy can pass through tissue to anadjacent electrode (forming a bipolar arrangement). The RF energy heatstissue (mostly ohmically) to coagulate the tissue and form a lesion.

The temperature of the fluid is preferably monitored for power controlpurposes. To that end, a thermistor 34 may be mounted within theexemplary therapeutic element 14. Other temperature sensing devices,such as a thermocouple and reference thermocouple arrangement, may beemployed in place of or in addition to the thermistor 34. As illustratedfor example in FIGS. 1-3, 6 and 7, the electrode 32 and thermistor 34are respectively connected to an electrical connector 36 in the handle16 by conductors 38 and 40 which extend through the shaft 12. The probe10 may be connected to a suitable RF power supply and control apparatus41 by a connector 43 that mates with the electrical connector 36. Thehandle 16 is provided with an opening 42 for this purpose.

The exemplary probe 10 may operate using a relatively simple controlscheme wherein lesions are formed by supplying power to the electrode 32at a predetermined level for a predetermined period of time. Whenforming pulmonary vein lesions, for example, about 35 watts for a periodof about 120 seconds is preferred. Should the temperature within theinflatable therapeutic element 14 exceed 90° C., power will be cut offby the control apparatus 41.

Accurate placement of the therapeutic element 14, particularly theporous region 26, is also important and color may be used to make iteasier for the physician to accurately position the therapeutic element.The porous region 26 may be one color while the non-porous regions 30may be another color. Alternatively, or in addition, the porous region26 may be relatively clear and the non-porous regions 30 may berelatively opaque. These properties may also be reversed. In oneexemplary implementation, the porous region 26 may be substantiallyclear and colorless, while the non-porous regions 30 may be a relativelyopaque blue color. This arrangement results in the porous region 26being a clear, colorless ring that is readily visible to the physician.

The exemplary therapeutic element 14 is provided with a stabilizingstructure 44 (FIG. 3). The stabilizing structure 44 preferably includesa flexible, non-conductive tubular member 46 and a tip member 48 on thedistal end of the tubular member. The flexibility of the tubular member46, which supports the electrode 32 and thermistor 34 and also providespassage for the conductors 38 and 40, prevents tissue perforation. Tipmember 48 includes a blunt distal surface that prevents tissueperforation. During assembly, the proximal end of the tubular member 46may be secured within the distal end of the shaft 12 with a suitableadhesive material 50 (such as cyanoacrylate) in the manner illustratedin FIG. 5.

The exemplary therapeutic element 14 illustrated in FIG. 3 is moldedsuch that the inner diameter of its proximal end 52 closely correspondsto the outer diameter of the shaft 12 and the inner diameter of itsdistal end 54 closely corresponds to the outer diameter of tip member48. The polymer coating 20 may be removed from the distal tip of theshaft 12 prior to assembly (as shown) or left in place and thetherapeutic element proximal end 52 positioned thereover. Cyanoacrylateor another suitable adhesive material may be used to secure thetherapeutic element proximal and distal ends 52 and 54 in place andprovide fluid tight seals.

With respect to materials, the porous region 26 is preferably formedfrom regenerated cellulose or a microporous elastic polymer.Hydro-Fluoro M material is another exemplary material. Materials such asnylons (with a softening temperature above 100° C.), PTFE, PEI and PEEKthat have micropores created through the use of lasers, electrostaticdischarge, ion beam bombardment or other processes may also be used.Such materials would preferably include a hydrophilic coating. Themicropores should be about 1 to 5 μm in diameter and occupy about 1% ofthe surface area of the porous region 26. A slightly larger porediameter may be employed. Because the larger pore diameter would resultin significant fluid transfer through the porous region, a salinesolution having a sodium chloride concentration of about 0.9% weight byvolume is preferred.

The non-porous regions are preferably formed from relatively elasticmaterials such as silicone and polyisoprene. However, other less elasticmaterials, such as Nylon®, Pebax®, polyethylene, polyesterurethane andpolyester, may also be used. Here, the inflatable therapeutic element 14may be provided with creased regions that facilitate the collapse of theporous electrode.

Additional information and examples of expandable and collapsible bodiesare disclosed in U.S. patent application Ser. No. 08/984,414, entitled“Devices and Methods for Creating Lesions in Endocardial and SurroundingTissue to Isolate Arrhythmia Substrates,” U.S. Pat. No. 5,368,591, andU.S. Pat. No. 5,961,513, each of which is incorporated herein byreference.

The therapeutic element 14 will typically be filled with conductivefluid prior to insertion of the surgical probe 10 into the patient. Asillustrated for example in FIGS. 2, 5, 6 and 7, the conductive fluid issupplied under pressure to the inflatable therapeutic element 14 by wayof an infusion lumen 56. The fluid exits the therapeutic element 14 byway of a ventilation lumen 58. The infusion and ventilation lumens 56and 58 extend from the distal end of the shaft 12 and through a pair ofapertures 60 and 62 in the handle 16. The proximal ends of the infusionand ventilation lumens 56 and 58 are provided with on-off valves 64 and66, which may be connected to the infusion and ventilation lines 68 and70 of a fluid supply device 72 such as, for example, an infusion pumpcapable of variable flow rates.

In a preferred implementation, the conductive fluid is continuouslyinfused and ventilated (at a rate of about 4-8 mils/minute for atherapeutic element 14 that is about 1.5 cm in diameter). Thus, inaddition to inflating the therapeutic element 14 and providing aconductive path from the electrode 32 to the tissue, the fluid cools thetherapeutic element so that heat is only generated within the tissue byvirtue of the passage of current therethrough.

The pressure of the fluid supplied by the fluid supply device 72 withinthe therapeutic element 14 should be relatively low (less than 20 psi)and may be varied by the fluid supply device in accordance with thedesired level of inflation, strength of materials used and the desireddegree of flexibility. The pressure, which is a function of the fluidflow rate, may be increased by increasing the fluid flow rate anddecreased by decreasing the fluid flow rate. The desired pressure may beinput into the fluid supply device 72 and pressure regulation may beperformed automatically by a controller within the fluid supply devicewhich varies the flow rate as appropriate. Alternatively, the flow rate(and pressure) may be varied manually by the physician.

Pressure within the therapeutic element 14 may be monitored in a varietyof ways. For example, flow through the infusion and ventilation lumens56 and 58 may be cut off for a brief period (about 1 second) so that thefluid pressure can be measured by a pressure sensor 74 associated withthe fluid supply device 72 (as shown) or with one of the valves 64 and66. Alternatively, a pressure sensor lumen (not shown) that is filledwith non-flowing fluid and extends from the interior of the therapeuticelement 14 to the pressure sensor 74 associated with the fluid supplydevice 72, or to a pressure sensor associated with one of the valves 64and 66, may be used without cutting off the fluid flow.

Varying the level of pressure within the therapeutic element 14 allowsthe physician to achieve the appropriate level of tissue contact, evenwhen the shaft 14 is not perfectly perpendicular to the target tissuearea and when the target tissue area is somewhat uneven. For example, astiffer therapeutic element 14 (which distorts the tissue) would bepreferred when the pulmonary vein ostium is relatively circular and whenthe ostium tissue is relatively healthy and pliable. A more flexibletherapeutic element 14 (which conforms to the tissue) would be preferredwhen the ostium is not circular and the ostium tissue is relativelycalcified and rigid due to disease. The ability to vary the stiffnessallows the physician to easily form a lesion that extends completelyaround the pulmonary vein or other bodily orifice by simply insertingthe distal portion of the probe 10 into the patient, positioning thetherapeutic element 14 in or around the bodily orifice, and applyingpower.

The present inventions are, of course, applicable to therapies in areasother than the treatment of atrial fibrillation. One such therapy is thetreatment of tumors, such as the cancerous tumors associated with breastcancer and liver cancer. One example of a surgical probe that is wellsuited for the treatment of tumors is illustrated in FIG. 8 andgenerally represented by reference numeral 76. Surgical probe 76 issubstantially identical to the probe 10 illustrated in FIGS. 1-7. Here,however, the probe includes a therapeutic element 78 that is formed fromthe same material as microporous region 26 and is entirely covered withmicropores 28. Although the size and shape will vary in accordance withthe intended application, the exemplary therapeutic element 78 isapproximately 5 mm to 50 mm in length and has a diameter of about 10 mmto 40 mm when inflated.

The exemplary surgical probe 76 illustrated in FIG. 8 may be introducedto a target location, such as within a cancerous tumor, using a varietyof techniques. Such techniques include laparoscopic techniques where theprobe will be introduced with a trocar, radially expandable port, orstep trocar expandable port. The therapeutic element 78 should bedeflated during the introduction process. Once the therapeutic element78 is at the target location, it may be inflated and the tissuecoagulated in the manner described above. The therapeutic element 78will be deflated and removed from the patient by way of the trocar,radially expandable port, or step trocar expandable port when thecoagulation procedure is complete.

The exemplary therapeutic element 78, as well as the other therapeuticelements described below that are intended to be expanded within thetissue of solid organ tissue or expanded within other tissue (see FIGS.9, 10 and 12-16), may include larger pores than therapeutic elementsthat are expanded prior to use or expanded within a hollow region insidean organ or other portion of the body. Pore sizes up to 0.1 mm areacceptable. The larger pore sizes may be used because the tight fitbetween the tissue and the inflated therapeutic element that resultsfrom the inflation of the therapeutic element within solid tissueincreases the effective flow resistance through the pores 28.Additionally, the small amount of electrically conductive fluid leakagethat may be associated with the use of larger pores will decrease ohmiclosses and allow power to be increased without tissue charring andvaporization.

Although its uses are not so limited, the exemplary surgical probe 80illustrated in FIGS. 9 and 10 is also particularly well suited fortreating tumors. Surgical probe 80 includes a hollow needle 82, amovable therapeutic assembly 84 that consists of a shaft 12′ and atherapeutic element 78′, and a movable stylet 86 that protects thetherapeutic element. The therapeutic assembly 84 and stylet 86 may beindependently moved proximally and distally relative to the hollowneedle 82 with slidable knobs 88 and 90 mounted on the handle 16′.

Surgical probe 80 may be introduced into the patient through a trocar orany appropriate port and the hollow needle 82 used to pierce throughtissue and enter a target location such as a tumor. The hollow needle 82may, alternatively, be used to introduce the surgical probe 80 into thepatient as well as to pierce through tissue and enter the targetlocation. In either case, once within the tumor or other targetlocation, the hollow needle 82 and stylet 86 may be withdrawn while thetherapeutic assembly 84 is held in place so that the therapeutic element78′ will remain within the target location. The therapeutic element 78′may then be inflated and the tissue associated with the target locationcoagulated in the manner described above. Once the coagulation procedureis complete, the therapeutic element 78′ will be deflated so that thestylet 86 can be slid over the therapeutic element. Both will then bepulled back into the hollow needle 82 so that the probe 80 can beremoved from the patient.

The size, shapes and materials used to form the hollow needle 82,therapeutic assembly 84 and stylet 86 will vary in accordance with theintended application.

With respect to tumor treatment, the exemplary hollow needle 82 ispreferably linear, is between about 1.3 cm and 7.6 cm in length, and hasan outer diameter that is between about 2.0 mm and 6.4 mm and an innerdiameter that is between about 1.5 mm and 5.8 mm. Suitable materials forthe hollow needle 82, which is preferably either straight or has apreset curvature, include stainless steel and Nitinol. The shaft 12′ ispreferably straight (although it can have a curvature) and rigid(although it may be malleable) and the stiffness is uniform from one endto the other. Suitable materials include stainless steel, Nitinol andrigid polymers. The diameter is preferably between about 0.6 mm and 4.6mm. The exemplary therapeutic element 78′ is approximately 19 mm to 38mm in length, a diameter of about 5 mm and 40 mm when inflated, with awall thickness of about 0.025 mm to 0.250 mm. The stylet 86 may beformed from materials such as stainless steel and Nitinol and preferablyhas an outer diameter that is between about 1.4 mm and 5.7 mm and aninner diameter that is between about 1.1 mm and 5.2 mm.

Turning to FIG. 11, surgical probes in accordance with other embodimentsof the present inventions, which are otherwise substantially identicalto the probe 10 illustrated in FIGS. 1-7, may include a heatedinflatable therapeutic element 92 in place of the porous therapeuticelement 14. The exemplary therapeutic element 92, which is supported onthe distal end of the shaft 12 in essentially the same manner astherapeutic element 14, can be inflated with water, hypertonic salinesolution, or other biocompatible fluids. The fluid may be supplied underpressure to the therapeutic element 92 by the fluid supply device 72 inthe manner described above. The pressure should be relatively low (lessthan 20 psi) and will vary in accordance with the desired level ofinflation, strength of materials used and the desired level offlexibility. The fluid will preferably be continuously infused andventilated for cooling purposes. Alternatively, the fluid may insteadfill the therapeutic element, remain there to be heated, and then beventilated after the lesion formation procedure has been completed.

A fluid heating element is located within the therapeutic element 92.The fluid heating element is preferably an electrode (not shown) thatmay be formed from metals such as platinum, gold and stainless steel andmounted on the support structure 44. A bi-polar pair of electrodes may,alternatively, be used to transmit power through a conductive fluid,such as isotonic saline solution, to generate heat. The temperature ofthe fluid may be heated to about 90° C., thereby raising the temperatureof the exterior of the therapeutic element 92 to approximately the sametemperature for tissue coagulation. It should be noted, however, thatthe therapeutic element 92 tends to produce relatively superficiallesions.

Suitable materials for the exemplary therapeutic element 92 includerelatively elastic thermally conductive biocompatible materials such assilicone and polyisoprene. Other less elastic materials, such as Nylon®,Pebax®, polyethylene and polyester, may also be used. Here, thetherapeutic element 92 will have to be formed with fold lines. Atemperature sensing element may also be provided. The heating electrodeand temperature sensing element will be connected to the electricalconnector 36 in the handle 18 by electrical conductors in the mannerdescribed above. Suitable power supply and control devices, whichcontrol power to based on a sensed temperature, are disclosed in U.S.Pat. Nos. 5,456,682, 5,582,609 and 5,755,715.

The exemplary therapeutic element 92 may also be used in conjunctionwith the surgical probes illustrated in FIGS. 8-10.

As illustrated for example in FIGS. 12-16, a surgical probe 94 inaccordance with a preferred embodiment of a present invention includes aplurality of tissue penetrating needles 96 that may be advancedoutwardly from, and retracted back into, the distal end of a shaft 12with a slidable knob 98. The number of needles 96, which may be glued,clamped or otherwise secured to the slidable knob 98, preferably rangesfrom 1 to 25. Each of the needles 96 includes a main body 100, asharpened tip 102 and an inflatable porous therapeutic element 104 withmicropores 28. The materials used to form the therapeutic element 104,as well as the conductive fluid used therewith, are the same as thosedescribed above with respect to the porous region 26. Hydro-Fluoro Mmaterial may also be used. When inflated, a fluid circulation space 106is defined between the main body 100 and the therapeutic element 104. Anelectrode 32 and a thermistor 34, which are positioned on the main body100 within the space 106, are connected to the electrical connector 36by conductors 38 and 40.

Although other configurations may be employed, the exemplary tissuepenetrating needles 96 preferably have the preset curvature illustratedin FIG. 13 and will assume this curvature when they are advancedoutwardly from the distal end of the shaft 12. To that end, suitableshape-memory materials for the needles 96 include stainless steel andNitinol. It should be noted that the needles 96 do not each have to havethe same curvatures or to even be curved at all. The needles 96 arepreferably about 0.25 mm to 1.25 mm in diameter and the curved region isabout 2.5 cm in length, while the diameter of the porous therapeuticelement 104 is about 1 mm to 10 mm when inflated and the thickness ofthe porous material is about 0.025 mm to 0.250 mm. In an implementationwith six (6) needles 96, the probe 94 would produce a lesion that isabout 2 cm to 3 cm deep and about 2 cm to 3 cm in diameter.

The exemplary tissue penetrating needles 96 each include infusion andventilation sub-lumens 108 and 110 with distal ends that respectivelyterminate at infusion and ventilation apertures 112 and 114 within thetherapeutic element 104. The proximal ends of the infusion andventilation sub-lumens 108 and 110 in each of the needles 96 areconnected to the infusion lumen 56 and ventilation lumen 58 by a pair ofsuitable plumbing junctions located within the handle 16″.

It should be noted that, because the needles 96 are moved back and forthrelative to the 12, the conductors 38 and 40 and sub-lumens 108 and 110should include some slack within the handle 16″.

In addition to conducting energy, the conductive fluid may becontinuously infused and ventilated through the therapeutic elements 104such that it draws heat away from the therapeutic element and the tissueadjacent thereto. This results in the formation of relatively deep,large volume lesions (as compared to devices with conventional needleelectrodes) without charring and coagulation. Cooling the therapeuticelements 104 and the adjacent tissue also greatly reduces the amount oftime required to form a large volume lesion (as compared to devices withconventional needle electrodes) because higher power is provided whenheat is removed from the area adjacent to the needles 96.

Each of the devices described above may be operated in both low voltagemodes and high voltage modes. In an exemplary low voltage mode, RFenergy will be applied that has a waveform shape and duration thatelectrically heats and kills tissue in the target region. A typicallesion within the heart could formed by delivering approximately 150watts of power for about 10 to 120 seconds at a radio frequency of 500kHz. Applied voltages may range from 60 to 100 volts rms.

Turning to high voltage modes, high voltage energy pulses can be used tokill, coagulate or otherwise modify tissue in at least three ways. Forexample, the creation of high voltage gradients within the tissuedielectrically breaks down tissue structures. In addition, ohmicallyheating tissue will coagulate tissue structures, while ohmically heatingto very high temperatures will vaporize tissue.

With respect to killing tissue through the dielectric breakdown of cellmembranes, relatively short (about 0.1 msec) high voltage (about 400 to4000 volts with 1000 volts being preferred) RF pulses that result involtage gradients at or above 500 volts/cm being induced in tissue willaccomplish the desired result. Turning to heating, a high voltage RFpulse (about 500 to 1200 volts in magnitude and about 50 to 100 msec induration) delivers relatively high power to tissue, thereby enablingvery rapid heating. Because the tissue is heated rapidly, there isessentially no convective heat loss during power application. Tissuevaporization can be performed through the use of high voltage energypulses with a pulse duration of about 250 msec to 1 sec. Additionalinformation concerning high and low voltage tissue modification isprovided in U.S. Pat. No. 6,023,638, which is incorporated herein byreference.

Although the present inventions have been described in terms of thepreferred embodiments above, numerous modifications and/or additions tothe above-described preferred embodiments would be readily apparent toone skilled in the art. It is intended that the scope of the presentinventions extend to all such modifications and/or additions and thatthe scope of the present inventions is limited solely by the claims setforth below.

We claim:
 1. A surgical probe, comprising: a relatively short shaftdefining a distal portion, a distal end and a proximal portion; a handleattached to the proximal portion of the shaft; a plurality of tissuepenetrating needles defining distal portions slidably mounted within theshaft and movable relative to the shaft such that the distal portions ofthe needles extend outwardly from the distal end of the shaft, theplurality of tissue penetrating needles each having a main body, asharpened distal tip, and at least one lumen; and a plurality ofinflatable therapeutic elements respectively mounted on the plurality ofneedles, wherein a distal end of the at least one lumen is disposedwithin the inflatable therapeutic element and a proximal portion of theat least one lumen is disposed with the handle, wherein the proximalportion of each lumen includes slack disposed within the handle.
 2. Asurgical probe as claimed in claim 1, wherein the relatively short shaftis relatively stiff.
 3. A surgical probe as claimed in claim 1, whereinthe relatively short shaft is malleable.
 4. A surgical probe as claimedin claim 3, wherein the proximal portion of the relatively short shaftis stiffer than the distal portion of the relatively short shaft.
 5. Asurgical probe as claimed in claim 1, wherein at least a portion of eachof the inflatable therapeutic elements comprises micropores.
 6. Asurgical probe as claimed in claim 1, wherein the distal portions of theneedles define a preset curvature.
 7. A surgical probe as claimed inclaim 1, wherein at least a portion of each of the inflatabletherapeutic elements comprises pores that are less than or equal to 0.1mm in diameter.
 8. A surgical probe system, comprising: a surgical probeincluding a handle, a relatively short shaft defining a distal portion,a distal end and a proximal portion, a plurality of tissue penetratingneedles each having a main body and a sharpened distal tip, the proximalportion of the shaft being attached to the handle, the plurality oftissue penetrating needles defining distal portions slidably mountedwithin the shaft and movable relative to the shaft such that the distalportions of the needles extend outwardly from the distal end of theshaft, a plurality of inflatable therapeutic elements respectivelymounted on the plurality of needles, wherein each needle includes atleast one lumen having a distal end disposed within the inflatabletherapeutic element and a proximal portion disposed with the handle,wherein the proximal portion of each lumen includes slack disposedwithin the handle; and a fluid source operably connected to theplurality of inflatable therapeutic elements and adapted to maintainpressure within the plurality of inflatable therapeutic elements at apredetermined level.
 9. A surgical probe system as claimed in claim 8,wherein the relatively short shaft is malleable.
 10. A surgical probesystem as claimed in claim 8, wherein at least a portion of each of theinflatable therapeutic elements comprises micropores.
 11. A surgicalprobe system as claimed in claim 8, wherein the fluid source comprises apump.
 12. A surgical probe system as claimed in claim 8, wherein the atleast one lumen includes an infusion lumen and a ventilation lumen thatare in fluid communication with the inflatable therapeutic elements; thefluid source includes an inlet connected to the surgical probeventilation lumen and an outlet connected to the surgical probe infusionlumen; and the fluid source continuously infuses fluid to and ventilatesfluid from the inflatable therapeutic elements by way of the outlet andinlet.
 13. A surgical probe system as claimed in claim 8, wherein thedistal portions of the needles define a preset curvature.
 14. A surgicalprobe system as claimed in claim 8, wherein at least a portion of eachof the inflatable therapeutic elements comprises pores that are lessthan or equal to 0.1 mm in diameter.
 15. A surgical probe system,comprising: a surgical probe including a handle, a relatively shortshaft defining a distal portion, a distal end and a proximal portion, aplurality of tissue penetrating needles each having a main body, asharpened distal tip, and at least one lumen, the proximal portion ofthe shaft being attached to the handle, the plurality of tissuepenetrating needles defining distal portions slidably mounted within theshaft and movable relative to the shaft such that the distal portions ofthe needles extend outwardly from the distal end of the shaft, and aplurality of inflatable therapeutic elements respectively mounted on theplurality of needles, wherein a distal end of the at least one lumen isdisposed within the inflatable therapeutic element and a proximalportion of the at least one lumen is disposed with the handle, whereinthe proximal portion of each lumen includes slack disposed within thehandle; and means, operably connected to the plurality of inflatabletherapeutic elements, for inflating the plurality of inflatabletherapeutic elements with electrically conductive fluid and maintainingpressure within the plurality of inflatable therapeutic elements at apredetermined level.
 16. A surgical probe system as claimed in claim 15,wherein the relatively short shaft is malleable.
 17. A surgical probesystem as claimed in claim 15, wherein at least a portion of each of theinflatable therapeutic elements comprises micropores.
 18. A surgicalprobe system as claimed in claim 15, wherein at least a portion of eachof the inflatable therapeutic elements comprises pores that are lessthan or equal to 0.1 mm in diameter.
 19. A surgical probe system asclaimed in claim 15, wherein the distal portions of the needles define apreset curvature.